The Remote Monitoring of Gout Feasibility Study (ReMonit Gout)

The ReMonit Gout Feasibility Study

In this feasibility trial, a digital follow-up treatment strategy with patient self-management app (Urika) and remote monitoring in specialist healthcare for patients with gout will be tested.

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Device: "Urika", a self-management application for patients with gout

Detailed Description

In this feasibility study various outcome measures will be assessed to determine whether the app (Urika) is viable, practical, and useful. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silje Søhus, MSc.; Phone Number: +4722451500; Email: silje.sohus@diakonsyk.no

Study Locations

• Norway
  • Oslo, Norway, 0319
    • Recruiting
    • Diakonhjemmet Hospital
    • Contact: Nina Østerås, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or non-pregnant, non-nursing female >18 years of age at screening
• Patients with a clinical diagnosis of gout
• Patients who fulfil the American College of Rheumatology (ACR)/EULAR classification criteria
• Serum urate level >360 μmol/L at inclusion
• Having a smartphone/tablet

Exclusion Criteria:

• Contraindication for urate lowering therapy
• Unstable medical conditions (e.g,, uncontrollable hypertension, impaired liver function); known stage 3b or higher chronic kidney disease (estimated glomerular filtration (eGFR) rate/creatinine clearance <45 mL/min); severe infection or gastrointestinal bleed
• Major co-morbidities (e.g., malignancies, severe cardiovascular disease, severe diabetes mellitus, severe respiratory diseases)
• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: To determine the feasibility of a patient self-management application (Urika) in patients with gout.; The intended purpose of the app is to support self-management for patients with gout that initiate urate lowering therapy.

Device: "Urika", a self-management application for patients with gout; The self-management software application (Urika) will include information videos on gout and treatment, reminders of daily medication and blood tests, a built-in algorithm for medical dosage escalation, visualization and log of serum urate levels, motivational gamification, asynchronous chat function patient-health professionals, and a platform for remote monitoring by health professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desirable feasibility level	Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility.	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App performance and functionality	Acceptable number of errors (≤5 errors per participant) in the performance and functionality experienced by the patients and project group members	Through study completion, an average of 3 months
Patient-reported software usability	Considered feasible if the System Usability Scale median score is ≥68 on a 0-100 scale, 100= best score	At 3 months
Patient and health professionals' training requirements	Measured by registering amount of time spent (minutes) on training	Pre-baseline for health professionals and at baseline for patients
Integration of workflow for health professionals	Measured by registering time spent on screening and enrollment	At screening and enrollment
Serum urate level	Considered feasible if there is available data on serum urate levels for ≥90% of patients for calculation of mean levels and proportion with low serum urate level	At 3 months
Patient-reported software functionality	Total number of reported errors related to the software functionality (e.g., downloading, login, registration of medication, reminders, access to videos, medication adherence, registration of blood test results, urate level graph, blood test history, chat, request new prescription). Considered acceptable feasibility if the number of errors are ≤5 per patient in the performance and functionality experienced by the patients and project group members.	Through study completion, an average of 3 months
Urate lowering therapy dose escalation	Considered feasible if patient-reported data and the medication history in the app monitored in the platform for health personnel is available for ≥90% of patients.	Through study completion, an average of 3 months
Patient-reported adherence to serum urate lowering therapy	Patient-reported Medication Adherence Report Scale (MARS-5), score range 5-25, higher scores mean better adherence. Considered acceptable feasibility if >=90% of the patients complete the instrument.	At 3 months
Acute gout flares	Number of acute gout flares	At 3 months
Side-effects of urate lowering therapy	Number of side-effects registered in the app or by study nurse or study coordinator	At 3 months
Adverse events	Number of adverse events (incl. serious adverse events) registered by study medical doctor, study nurse or study coordinator	At 3 months
Patient satisfaction with the follow-up care	Measured by a numeric rating scale (NRS) 0-10, higher scores mean better outcome. Considered acceptable feasibility if >=70% of the participants score >=5 on the NRS.	At 3 months
Knowledge of gout and recommended treatment	Measured by the Gout Knowledge Questionnaire, 0-10, higher scores mean better outcome. Considered acceptable feasibility if there is available total score data for >=90% of the patients.	At baseline and 3 months
Pain related to gout	Measured by a numeric rating scale (NRS) 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.	At 3 months
Activity limitations	Measured by Work Productivity and Activity Impairment (WPAI) item no.6, 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.	At 3 months
Number of consultations in specialist or primary healthcare	Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported visits in specialist or primary healthcare	At 3 months
Costs and time for traveling	Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported time for travelling to the hospital	At 3 months
Sick leave and time off work	Considered acceptable feasibility if there is available data for ≥90% of participants using self-report	At 3 months
Eligible patients per month	Number of eligible patients per month.	At enrollment
Recruitment rate	Acceptable recruitment rate is ≥50% of eligible patients.	After enrollment
Patient dropout	Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.	At 3 months
Trial logistics	Acceptable overall trial logistics (Identification, screening, recruitment, patient training, data collections, monitoring blood test results, renewal of prescriptions) evaluated as Yes vs. No by the study group.	At 3 months
Patients' app use: videos watched	Count the number of videos watched per participant. Considered acceptable feasibility if ≥70% of the participants have watched at least 1 video.	Through study completion, an average of 3 months
Patients' app use: registrations of daily medication adherence	Count the number of registrations of daily medication adherence. Considered acceptable feasibility if ≥70% of the participants have registered at least 1 adherence.	Through study completion, an average of 3 months
Patients' app use: registration of serum urate levels	Count the number of registered serum urate levels. Considered acceptable feasibility if ≥90% of the patients register their serum urate level monthly.	Through study completion, an average of 3 months
Patients' app use: chat messages	Count the number of chat messages. Considered acceptable feasibility if ≥70% of the participants register at least 1 chat message.	Through study completion, an average of 3 months
Patients' app use: flare registering	Count the number of flare registering. Considered acceptable feasibility if ≥10% of the participants register 1 flare.	Through study completion, an average of 3 months
Potential risk and challenges	Incidence of hinders that could harm a successful clinical evaluation of the app in a large randomised, controlled trial.	At 3 months
Patient-reported experiences and perceived benefits with the app	Open responses will be collected in semi-structured interview. No scales or instruments will be used	At 3 months
Patient-reported satisfaction with the app	Measured by a numeric rating scale (NRS) 0-10, higher scores mean better outcome. Acceptable feasibility if >=70% of the participants report score >=5, otherwise considered not acceptable feasibility.	At 3 months
Health related quality of life	Measured by the Euro Quality of Life 5 Dimensions 5 Levels, each item is scored 1-5, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.	At 3 months

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Investigators: Principal Investigator: Nina Østerås, Prof., Diakonhjemmet Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: 23/02662; 2023054 (Other Grant/Funding Number: South-Eastern Norway Health Authority)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No